FDA.reportPublic FDA data

TUNED LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30233391613023339161TUNED LTD1N2026-01-01Harimon Gan Yoshiya Central IL 38850

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3074831877735411K251208Tuned Self-Fitting Mobile AppSCR2025-09-26
3074832050364600K223848Intrisound™ Tuned Lumen® 155 Hearing AidsQUH2023-09-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SCR12025-09-26
QUH12023-09-08

PMN#